Methods, devices, and kits for treating mitral valve prolapse

ABSTRACT

Described here are methods, devices, and kits for treating a prolapsed valve leaflet. The devices generally comprise a flexible cord, a first anchor attached to the cord at its distal end, and a second anchor slidably attached to the cord. The first anchor may be configured to secure the cord to cardiac tissue located below a prolapsed valve leaflet and the second anchor may be configured to secure into the prolapsed valve leaflet. Also described are methods for treating a prolapsed valve including the steps of securing a first anchor to cardiac tissue located below the prolapsed mitral valve leaflet, securing a second anchor to the prolapsed mitral valve leaflet, tensioning a cord connecting the two anchors and securing the cord. Kits including the described devices are also provided.

FIELD

The methods, devices, and kits described here are in the field ofcardiac valve repair, and more specifically, in the field of treatingmitral valve prolapse.

BACKGROUND

The mitral valve comprises two leaflets attached to the mitral valveannulus, which are supported towards their free edge by cords (chordaetendinae) fastened to the internal wall of the ventricle and to thepapillary muscles. However, sometimes one or both of the valve leafletsbecome loose, due to failure or loosening of one or several of thesecords. The valve then prolapses and its bloodtight seal becomescompromised, causing the blood to flow back into the left atrium duringsystole.

Some solutions to this prolapse problem have focused on either replacingthe whole valve with an artificial one, or repairing the part of thevalve that is diseased in order to restore normal function. Othersolutions focus on clipping the valve leaflets together in order toobtain better leaflet coaption. Most of these solutions are surgical, asopposed to percutaneous, in nature, requiring an incision into thethoracic cavity (e.g., a median sternotomy) and into the heart. Thistype of surgery also necessitates arresting the heart, and thus the useof a extracorporeal circulation system such as a heart-lung-bypassmachine to take over the heart function while the patient's heart isarrested. This surgery is incredibly invasive, causing high risks andmorbidity to those eligible. In addition, the use of a heart-lung-bypassmachine poses an inflammatory reaction risk as components of the bloodcan get activated while circulating in the machines tubes, reservoirs,pumps, and oxygenators, which are made of foreign materials. Because ofthe risks and invasiveness of the surgery, the recovery time istypically quite lengthy.

Accordingly, it would be advantageous to have methods, devices, and kitsfor treating mitral valve prolapse, which are less invasive and poseless risks to the patient than typical open heart surgery. It would alsobe advantageous to have alternative methods and devices for treatingmitral valve prolapse.

SUMMARY

Described here are methods, devices, and kits for treating a prolapsedvalve leaflet, such as a mitral valve leaflet or a tricuspid valveleaflet. In general, the devices include a flexible cord having aproximal and a distal end, a first anchor, and a second anchor. Thefirst and second anchors may be attached to the cord. Either or both ofthe first and second anchors may be slideably attached to the flexiblecord. Either the first or second anchors may be attached to the distalend of the flexible cord.

In some variations, the devices comprise a flexible cord, having aproximal end and a distal end, a first anchor attached to the cord atits distal end and configured to secure the cord to cardiac tissuelocated below a prolapsed valve leaflet, and a second anchor slidablyattached to the cord and configured to secure into the prolapsed valveleaflet. The cardiac tissue may be selected from the group consisting ofa papillary muscle and a ventricular wall according to some variations.As described above, the valve leaflet may be a mitral valve leaflet or atricuspid valve leaflet.

The second anchor may include two legs that are configured to piercetissue, and in some variations the second anchor further comprises aneyelet. The first anchor may have a tissue piercing tip, and in somevariations, the tip comprises two legs, which may or may not beconfigured to expand after they are secured into tissue.

At least one of the first or second anchors may be made from a shapememory material, and in some variations, the shape memory material is anickel titanium alloy. Similarly, the cord may be made from a materialselected from the group consisting of non-polymeric fabrics, polymers,and mixtures thereof. In some variations, the cord is made from anon-polymeric fabric and polymer mixture. The devices may furthercomprise a fastener for securing the second anchor into the prolapsedvalve leaflet.

The described methods for treating a prolapsed valve leaflet typicallyinclude securing a first anchor to a cardiac tissue located below theprolapsed valve leaflet (wherein the first anchor is attached to aflexible cord), securing a second anchor into the prolapsed valveleaflet (wherein the second anchor is attached to the flexible cord),and tensioning the cord after the first and second anchors have beensecured. The position of the prolapsed valve leaflet may be adjusted bycoordinating the tension of the cord and the location of the leaflet.For example, a practitioner (e.g., a doctor, surgeon, technician, etc.)may move the prolapsed valve into a correct (e.g., non-prolapsed)position by adjusting the position of the valve leaflet directly bypushing against the anchor attached to the valve leaflet (e.g., usingthe fastener to push against the anchor and applying tension to thecord). Once the valve leaflet is positioned correctly, the practitionercan secure cord to maintain the correct position of the valve leaflet.The valve leaflet position may be adjusted in real-time in a beatingheart (e.g., using echocardiography). For example, the valve leaflet maybe repositioned while monitoring mitral regurgitation (MR). Once any MRis reduced or eliminated, the cord can be secured.

Any appropriate prolapsed valve leaflet may be treated as describedherein, including mitral valve leaflets and tricuspid valve leaflets.Further, these methods may be performed using one or more catheters orusing non-catheter surgical methods, or using a combination ofcatheter-type surgical methods and non-catheter type surgical methods.

In some variations, the flexible cord may be advanced via one or morecatheters to the proximity of the prolapsed valve leaflet in ananterograde approach (e.g., from above the mitral valve). For example,the first anchor can be attached to the distal end of the flexible cordso that it can be secured to the cardiac tissue located below theprolapsed valve leaflet. In this example, the second anchor is slideablyattached to the flexible cord, so that it can be secured to theprolapsed valve leaflet. Alternatively, the flexible cord may beadvanced via a retrograde approach (e.g., from below the mitral valve).In this variation the first anchor can be attached to the distal end ofthe flexible cord so that it can be secured to the prolapsed valveleaflet, while the second anchor is slideably attached to the flexiblecord, so that it can be secured to the cardiac tissue located below theprolapsed valve leaflet.

In one variation the method provides for treating a prolapsed mitralvalve including the steps of advancing a flexible cord (having a firstanchor attached at its distal end) to the proximity of a prolapsedmitral valve leaflet, securing the first anchor to cardiac tissuelocated below the prolapsed mitral valve leaflet, securing a secondanchor slidably attached to the cord into the prolapsed mitral valveleaflet, and tensioning the cord and securing the second anchor. In allof the methods described herein, the cardiac tissue located below theprolapsed valve (to which one of the anchors is secured) may be selectedfrom the group consisting of a papillary muscle and a ventricular wall.

These methods may further comprise fixing the cord in its tensionedposition, for example, by applying a fastener to the cord. The methodsmay also comprise cutting the cord, for example, by advancing a loopedcutting wire over the cord, positioning the looped cutting wire proximalof the second anchor, and pulling on the cutting wire to cut the cord.

Kits for treating a prolapsed valve leaflet (e.g., a mitral valveleaflet) are also described. In general the kits comprise a flexiblecord having a proximal end and a distal end, a first anchor attached tothe cord at its distal end, a second anchor for slidable attachment tothe cord, and at least one catheter for delivery of the flexible cord tothe proximity of the prolapsed valve leaflet. In some variations, thefirst anchor is configured to secure the cord to cardiac tissue locatedbelow a valve leaflet, and the second anchor is configured to secureinto a prolapsed valve leaflet.

The kit may further comprise at least one additional catheter, a cuttingwire for cutting the cord, a fastener, and/or instructions on how to usethe contents of the kit. At least one of the first or second anchors maybe made from a shape memory material, for example, a nickel titaniumalloy. Similarly, the cord may be made from a material selected from thegroup consisting of non-polymeric fabrics, polymers, and mixturesthereof. In some variations, the cord is made from a non-polymericfabric and polymer mixture.

The first anchor may have a tissue piercing tip, and in some variationsthe tip comprises two legs. In these variations, the legs may beconfigured to expand after they are secured into tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts one method of accessing a prolapsed leaflet of a mitralvalve using a trans-septal catheter, in accordance with the methods anddevices herein described.

FIG. 2 provides a magnified view of FIG. 1, where a first catheter hasbeen introduced through the trans-septal catheter and into the leftatrium.

FIG. 3 depicts the application of suction from the first catheter to thepapillary muscle.

FIG. 4A provides a magnified view of the distal end of the firstcatheter, which is temporarily adhered to the papillary muscle viasuction.

FIG. 4B provides an illustrative example of a suitable first anchor, inaccordance with the methods, devices, and kits described herein.

FIG. 5 provides a magnified view of the deployment of the first anchorinto the papillary muscle tissue.

FIG. 6 depicts the cord secured to the papillary muscle via the firstanchor, as the first catheter is being removed.

FIG. 7 provides an illustration of the second anchor being advanced tothe proximity of the prolapsed mitral valve leaflet.

FIG. 8 provides an enlarged view of a suitable second anchor asdescribed herein.

FIG. 9 shows an illustrative method of positioning the second anchoradjacent to the prolapsed mitral valve leaflet.

FIG. 10 shows an illustrative method of deploying the second anchor intothe prolapsed mitral valve leaflet.

FIG. 11 provides an illustrative depiction of the advancement of a thirdcatheter carrying a fastener.

FIG. 12 shows the fastener being positioned and deployed adjacent to thesecond anchor, after the prolapsed valve has been positioned and thecord has been pulled to tension the cord so that the prolapse has beencorrected.

FIG. 13 shows the release of the fastener and removal of the thirdcatheter.

FIG. 14 provides an illustrative depiction of the advancement of acutting wire.

FIG. 15 shows the removal of the cutting wire after excess cord has beencut immediately proximal to the fastener.

FIGS. 16A-16C illustrate a cutting wire cutting a cord.

DETAILED DESCRIPTION

Described here are methods, devices, and kits for treating valveprolapse (such as mitral valve prolapse). In general, the methods,devices, and kits relate to the use of a cord that can be secured intocardiac tissue located below the valve leaflets (e.g., the papillarymuscles or the ventricular wall), coupled to a prolapsed valve leaflet,and then tensioned to correct the prolapse. While the majority of thedescription herein relates to the use of these devices and kits during apercutaneous or intravascular procedure, the devices and kits may alsobe used during open surgical procedures as well.

Devices

In general, the devices for treating a prolapsed mitral valve leafletcomprise a flexible cord, having a proximal end and a distal end, afirst anchor attached to the cord at its distal end, and a second anchorslidably attached to the cord. In some variations, the first anchor isconfigured to secure the cord to cardiac tissue located below theprolapsed mitral valve leaflet, and the second anchor is configured tosecure into the prolapsed mitral valve leaflet. In some variations, thefirst anchor is configured to secure into the prolapsed mitral valveleaflet, and the second anchor is configured to secure the cord tocardiac tissue located below the prolapsed mitral valve leaflet.

As will be described in more detail below, the first anchor may have atissue piercing tip, which in some variations comprises two legs thatmay be configured to expand after securing into cardiac tissue (e.g., apapillary muscle and a ventricular wall). Similarly, the second anchormay comprise two legs that are configured to pierce mitral valve leaflettissue, and may further comprise an eyelet. Either of the anchors may bemade from a shape memory material such as a nickel titanium alloy.

The cord is typically flexible so that it can be maneuvered through acatheter, and may, for example, be made from a material selected fromthe group consisting of non-polymeric fabrics, polymers, or mixturesthereof. In some variations, the cord is made from a polymeric andnon-polymeric fabric mixture, such as a PTFE (polytetrafluoroethylene,including expanded polytetrafluoroethylene) fabric, although anysuitable artificial or biological material may be used. It should benoted that the cord is of such a length as to enable it to bemanipulated outside of the patient's body. Thus, the suitable length ofthe cord is determined in large part by the method of access (e.g., lesscord will be necessary if the prolapsed mitral valve leaflet is accessedvia the jugular rather than the femoral).

The device may further comprise a fastener. In this way, after the cordhas been secured into cardiac tissue by the first anchor, and coupled toa prolapsed mitral valve leaflet by a second anchor, it may be pulledtight or tensioned, and fastened in place. For example, the cord may befastened at a tension that helps correct the valve leaflet prolapseafter the valve has been repositioned, as described herein. A moredetailed description of the device and all of its optional componentswill be provided in the discussion of the methods below.

Methods

In general, the methods for treating a prolapsed valve leaflet comprisesecuring a first anchor to cardiac tissue located below the prolapsedvalve leaflet (wherein the first anchor is attached to a flexible cord),securing a second anchor into the prolapsed valve leaflet (wherein thesecond anchor is attached to the flexible cord), and securing the cord.

When a catheter is used to apply the device to treat a prolapsed valve,the application may be performed either anterograde (e.g., in the usualdirection of flow of blood, typically above the valve) or retrograde(e.g., in the direction against the normal flow of blood, typically fromblow the valve). Although most of the examples of devices and methodsdescribed herein illustrate the anterograde approach, it should beunderstood that the retrograde approach may also be used.

One variation of the method for treating a prolapsed valve leaflet(e.g., a mitral valve leaflet) comprises advancing a flexible cordhaving a first anchor attached at its distal end to the proximity of theprolapsed valve leaflet, securing the first anchor to cardiac tissuelocated below the prolapsed valve leaflet (e.g., papillary muscle or theventricular wall), securing a second anchor slidably attached to thecord into the prolapsed mitral valve leaflet, and tensioning the cordafter the second anchor has been secured into the prolapsed mitral valveleaflet. The prolapse of the valve leaflet may be corrected so that itdoes not prolapse by moving the valve into the correct non-prolapsedposition (e.g., by pushing against the anchor with a fastener, and bytensioning the cord between the anchors so that the valve leaflet doesnot prolapse). The cord may be secured in using a fastener. The valveleaflet may be moved by manipulating the cord, by using a catheter, aprobe, or by any other appropriate positioning step. For example, thedistal end of a catheter may be used to position the valve leaflet, orthe fastener may be used to position the valve leaflet. In somevariations the valve leaflet is manipulated after an anchor has beeninserted into (or through) the valve leaflet, but before the tension onthe cord is secured by the fastener. Once the leaflet is positioned, thecord may be optimally tensioned to maintain the corrected position, andthe cord may be secured into place and cut.

For example, FIG. 1. shows a cross-section of heart (100), having aprolapsed mitral valve leaflet (104). To access the prolapsed mitralvalve leaflet (104), a trans-septal catheter (102) is introduced intothe inferior vena cava (106), which is in turn accessed through one ofthe femoral veins. The trans-septal catheter (102) is then advanced upthrough the right atrium (108) and through the interatrial septum (110).Examples of the trans-septal approach are described in U.S. Pat. No.6,743,239, U.S. Pat. No. 6,695,866 (herein incorporated by reference intheir entirety). The catheter should be flexible and steerable, so thatit can be maneuvered through the tortuous anatomy of the vasculature.For example, the catheter may include a steerable sheath, wherein atleast part of the sheath (e.g., the distal end) is steerable in one ormore directions. Thus, the sheath may be inserted trans-septally andoriented (e.g., towards the anterior commissure) so that anothercatheter may pass through the sheath and be further steered towards thevalve leaflet and/or the cardiac tissue located beneath prolapsed valveleaflet.

As described above, FIGS. 1-15 depict one method of accessing theprolapsed mitral valve leaflet (104) (e.g., the anterograde approach),however different methods of access are also suitable. For example, acatheter may also be introduced via the jugular vein, may be introducedthrough the right femoral artery, and advanced up to the left atrium(112) by crossing the aortic valve, or may be introduced via the carotidor subclavian arteries. Thus, the order of the steps described in themethod may be adapted to suit these variations. For example, in aretrograde approach the valve is accessed from below, and the distal endof the cord is attached to a first anchor adapted to secure to the valveleaflet, and the second anchor is adapted to secure to the cardiactissue located beneath prolapsed valve leaflet and be slideablyconnected to the cord.

Any appropriate visualization technique may be used to help thepractitioner visualize the valve anatomy, and to manipulate or steer thecatheters. For example, intracardiac echo, or transesophageal echo maybe used. Thus, the devices described herein may be adapted to enhancevisualization of the devices when used with any of the techniques. Forexample, the devices may include contrasting agents, and they mayinclude electron dense or radioopaque regions, etc. In addition, rapidventricular pacing, or adenosine IV administration may allow fortransient and reversible cardiac arrest in order to stabilize theleaflets and papillary muscles and facilitate targeting.

FIG. 2 provides a magnified view of the heart cross-section of FIG. 1.Shown in FIG. 2 is a catheter (200) introduced into trans-septalcatheter (204) (e.g., a trans-septal sheath). Catheter (200) is carryinga flexible cord (202). Catheter (202) is advanced through thetrans-septal catheter (204) to the left atrium (206), and down throughthe mitral valve opening (208), and into the left ventricle (210). Insome variations, the trans-septal sheath 204 has a steerable (ordirectional) tip to help guide the catheter(s) towards the leaflet andcardiac tissue beneath the leaflet. As can be seen in FIG. 2, mitralvalve leaflet (212) is prolapsed so that it can no longer prevent theback flow of blood into the left atrium when the ventricle contracts.

FIG. 3 shows catheter (300) being advanced to cardiac tissue locatedbeneath prolapsed mitral valve leaflet (302), and specifically to thehead of papillary muscle (304). In some variations, the catheter may besteerable (e.g., the tip may be at steerable in at least one direction).Thus, the trans-septal sheath (204) and the catheter together may beused to guide the catheter (300). The catheter (300) is connected to avacuum source (not shown) located outside of the patient's body. In somevariations, the edges of the distal end of catheter (300) are designedso as to maximize contact with the papillary muscle and to minimizeaspiration of blood into the catheter during the time suction isapplied. For example, the distal end of the catheter may be adapted toconform to the cardiac tissue that it contacts (e.g., the head of thepapillary muscle). It should be noted, however, that while FIG. 3depicts catheter (300) being advanced to the head of papillary muscle304), that the catheter may be advanced to any suitable cardiac tissuelocated below the prolapsed mitral valve (302). For example, catheter(300) may be advanced to a location along the side or base of theventricular wall. That is, the catheter need not be advanced to alocation directly vertical of the prolapsed mitral valve leaflet.

FIG. 4A provides a magnified view of the distal end of the catheter(300) from FIG. 3. As shown there, catheter (300) has been advanced tothe head of papillary muscle (304), and is held in place by lightsuction. In general, adequate suction will be applied to form a sealbetween the catheter and the head of the papillary muscle. The suctionis sufficient to stabilize the catheter to the head of the papillarymuscle, but does not damage or otherwise harm the papillary muscle, aswould be observed by an ordinary artisan. Catheter (300) is carryingcord (400), which has a first anchor (402) at its distal end. The firstanchor (402) may be secured to the cord (400) in any suitable manner.For example, the cord (400) may be tied to first anchor (402), or firstanchor (402) may be welded, bonded, or otherwise adhered to cord (400).Also shown is a plunger or piston-like mechanism (404), which whenadvanced distally (shown by arrows), deploys first anchor (402) out fromthe distal end of catheter (300) and into the head of papillary muscle(304). The plunger or piston-like mechanism is typically maneuvered bythe practitioner, outside of the patient's body. While a plunger, orpiston-like mechanism is shown in FIG. 4A, any suitable deploymentmechanism may be used to deploy first anchor (402). For example, ahydraulic mechanism may be used, or the anchor may be deployed with theuse of an expandable balloon.

FIG. 4B provides a magnified view of the first anchor (402) shown in anunexpanded (top view) and expanded (bottom view) configuration. As shownby FIG. 4B, first anchor (402) has a tissue piercing tip (406). Whilethe tissue piercing tip (406) of first anchor (402) is shown as beingsharp or pointed, it need not be. Indeed, any tip configured to piercetissue (whether blunt or sharp) is suitable. The tip of first anchor(402) in the variations shown in FIGS. 4A and 4B comprise two legs(408), which are configured to expand after they are secured intocardiac tissue (as shown by the arrows in the top picture in FIG. 4B,and as shown expanded in the bottom picture in FIG. 4B). The legs of theanchors described herein may be extended passively, actively or both tohelp secure the anchor in the tissue. For example, the legs may beextended actively by releasing them from tension (e.g., compression) orby using a shape-memory alloy, as described above. The legs may bepassively extended after insertion into the tissue by pulling“backwards” on the anchor after it has been inserted into the tissue;the legs of the anchor may act as barbs, and expand into the tissue.

First anchor (402) may comprise any suitable number of legs. Indeed, insome variations, it might be preferable for first anchor (402) to haveone, two, three or more legs. First anchor (402) is also shown as havinga t-bar (410) near its proximal end, although it need not have one.Having a t-bar (410) at its proximal end may help further secure theanchor into cardiac tissue. In some variations the t-bar may provide asurface against which force can be applied to drive the anchor into atissue. It may also be beneficial to have at least a portion of thefirst anchor (402) made from a shape memory material such as a nickeltitanium alloy. However, any other flexible, yet sturdy, biocompatiblematerial may be used. While first anchor (402) is shown in FIGS. 4A and4B as having a modified shipping anchor configuration (i.e., having av-shaped distal end with a t-bar), any suitable configuration may beused. Typically, first anchor (402) is of a size suitable to secure intocardiac tissue. For example, the anchor may be between about 3 and about12 mm long, or between about 5 and about 10 mm long. In some variations,the anchor may be about 8 mm long. In some variations, the first anchoris longer than it is wide.

FIG. 5 simply demonstrates the first anchor (402) being deployed intothe head of papillary muscle (304) by distal advancement of the plungeror piston-like mechanism (404). After the first anchor (402) is fullydeployed into the head of papillary muscle (304), its legs may expand tofurther secure the anchor into the cardiac tissue, as shown in thevariation of FIG. 4B. Cord (400) may be pulled proximally to ensurefirst anchor (402) is firmly and adequately secured to the head ofpapillary muscle (304) or other cardiac tissue as the case may be. Ifthe anchor is not firmly secured, the deployment mechanism (e.g.,hydraulic, plunger, or piston (404)) may be retracted proximally, theanchor withdrawn, and then re-deployed by the deployment mechanism(e.g., by distal advancement of a plunger or piston (404)).

After the first anchor (402) has been firmly secured to cardiac tissuelocated beneath the prolapsed mitral valve (e.g., into the head of thepapillary muscle, 304), the suction to catheter (300) is released, andcatheter (300) is withdrawn proximally (shown by arrows), leaving thefirst anchor (402) attached to cord (400) in place, as shown by FIG. 6.FIG. 7 provides an illustrative depiction of advancement of secondanchor (700) along cord (400). Second anchor (700) is slidably attachedto the cord (400) and is configured to secure into the prolapsed mitralvalve leaflet. The second anchor is typically slid onto the cord (400)proximal of the patient's body, and introduced and advanced to the siteof the prolapsed mitral valve with the aid of a catheter (702). In FIGS.7, 9 and 10, the catheter introducing the anchor is indicated by a line(702). Any appropriate introducer for positioning, releasing andsecuring the anchor may be used for example, the second anchor may bepositioned and released as described above for the first anchor. Apractitioner may thread the second anchor onto the cord outside of thebody. After the second anchor has been attached to the prolapsed mitralvalve leaflet (302), the valve leaflet may be repositioned to correctthe prolapse, and tension may be applied to the cord (400) to maintainthe proper position of the anchors to correct the prolapse.

FIG. 8 shows an illustrative depiction of a second anchor (700) in amagnified fashion. Shown there is anchor (700) slidably attached to cord(400). In this variation, second anchor (700) has eyelet (800) allowingfor such slidable attachment (i.e., in this variation, the cord is slidthrough eyelet 800). The second anchor of this variation also has legs(802) that are configured to pierce tissue, and preferably, the tissueof a prolapsed mitral valve leaflet. Again, the legs of the secondanchor need not terminate in sharp or otherwise pointed distal tips, solong as the anchor has been suitably designed to pierce tissue.Similarly, as with the first anchor described in detail above, thesecond anchor may be made of any suitable material, and be of a sizesuitable to secure into a prolapsed mitral valve leaflet. For example,in some variations the anchor is between about 4 mm and about 8 mm(e.g., the tips of the legs span between about 4 mm and about 8 mm). Insome variations, the anchor is about 6 mm.

As noted above, the second anchor (700) may be advanced to prolapsedmitral valve leaflet (302) via catheter (702). Catheter (702) istypically steerable, or otherwise maneuverable so that it can bemaneuvered through trans-septal catheter (204) and to the prolapsedmitral valve leaflet (302). Visualization techniques, such asfluoroscopy may be useful in this respect. The second anchor may beattached to the catheter, and released only after it has been attachedto the valve leaflet. In some variations, the second anchor may pierce(e.g., pass completely through) the valve leaflet when the second anchoris secured to the valve leaflet. For example, the second anchor may bepositioned by abutting the valve leaflet with one or more of the anchorlegs, so that the practitioner can cause the anchor legs to penetrateinto the valve leaflet. The anchor may be secured to the margin (e.g.,within about 5 mm from the edge of the leaflet) or in any otherappropriate region of the valve leaflet. In the variation shown in FIG.9, the legs of anchor (700) are positioned so that they may be insertedinto the valve leaflet. For example, the legs may straddle the edge ofprolapsed mitral valve leaflet, or one of the legs may hook onto themitral valve leaflet (302). The second anchor (700) should preferably bepositioned at the edge of the mitral valve leaflet, but the legs of theanchor may secure into a deeper margin of the prolapsed mitral valveleaflet if desirable. In some variations, it may be preferable for thepractitioner to hook the lower edge of the prolapsed mitral valveleaflet with the lower leg of the second anchor, before the legs arecollapsed or expanded (as the case may be) into the leaflet tissue.

FIG. 10 provides an illustrative depiction of the second anchor (700)deployed into the prolapsed mitral valve leaflet (302). The deploymentof second anchor (700) may occur in any number of ways. For example, arelease mechanism may be activated from outside the patient's body. Forexample, the release mechanism may comprise a reversibly releasablelatch within catheter (702). Having a reversible latch, for example, maybe quite beneficial so that the practitioner may have multiple tries atdeploying the second anchor, if the first try results in misplacement.The release mechanism, may be made of a cable with a releasable latch atits distal end, for example, or something similar. As described above,the legs of the anchor may be deployed into the tissue by changing theconfiguration of a shape-memory material or by releasing from a loadingconfiguration (e.g., compressed) into a delivery (e.g., expanded)configuration.

As described above, the legs of the second anchor can be secured intothe prolapsed valve leaflet by any suitable mechanism. For example, thesecond anchor may be made from a self-expanding material, such as ashape memory material (e.g., a nickel titanium alloy), such that, whenit is released, its legs expand (or compress or collapse as the case maybe) into the tissue of the mitral valve leaflet. Similarly, anexpandable balloon may be used to force the legs of the anchor into theprolapsed mitral valve leaflet tissue.

FIG. 11 shows a schematic representation of a catheter (1100) having areleasable fastener (1104) at its distal end (1102) being advanceddistally through trans-septal catheter (204). As shown, the distal end(1102) and releasable fastener (1104) have lumens therethrough, whichallow them to be thread or slid over cord (400). Catheter (1100) isadvanced distally as shown by the arrows, and will be advanced until thereleasable fastener (1104) is positioned immediately adjacent to thesecond anchor (700) as shown by FIG. 12. The position of the valveleaflet is then adjusted (e.g., to correct the prolapse and eliminatemitral regurgitation). Thus, the fastener (1104) may be used to positionthe valve leaflet. For example, the fastener may be used to push againstthe second anchor (700) (e.g., by pushing against the eyehole of thefastener). At the same time, the cord (400) can be tensioned to correctthe position of the valve leaflet. This position can be maintained bysecuring the cord (e.g., with the fastener (1104)). A practitioner mayadjust the position of the valve leaflet (e.g., by adjusting theposition of the fastener and the tension of the cord) while visualizingthe heart to correct a prolapse. Correction is obtained whenregurgitation into the left atrium disappears or is significantlyreduced. The correction can be monitored, for example, by intracardiacecho or transesophageal echo. Thus, the position of the valve leafletcan be adjusted in real time while monitoring any regurgitation. Oncethe position is optimized, the fastener (1104) may be secured.

As described above, the releasable fastener may be positioned tooptimally tension the cord (400) so that the distance between theanchors adequately corrects the position of the prolapsed leaflet. Thereleasable fastener is then released and fastened or crimped to the cord(400) to secure the cord in this position.

The prolapsed leaflet may be repositioned to correct the prolapse by thepractitioner manipulating the valve leaflet, and by applying tension(e.g., pulling) on the cord. In some variations, the practitioner mayuse a separate manipulator to move the valve leaflet and to secure thecord position. For example, a wire or another catheter (e.g., separatefrom the catheter used to deliver the fastener) may be used to pushagainst the leaflet or anchor.

The fastener may be released and secured (e.g., crimped) in any suitableway. For example, the fastener may be held in catheter (1102) by asheath, and once the sheath is removed, the fastener may be released.Similarly, the fastener may be attached to the catheter by anelectrolytic joint, and once it is desired to detach the fastener,electricity may be applied to sever the joint via electrolysis. Thefastener may also be released via the use of a push-pull wire. Anynumber of suitable techniques may also be used with respect to crimpingof the fastener. For example, the fastener may be made of aself-collapsing material, such as a shape memory material, that wouldcollapse tightly upon itself after being released. An expandable balloonmay also be used to crimp the fastener. That is, as the expandableballoon is inflated, the fastener is crimped tightly upon itself underthe pressure. After the fastener is positioned and crimped in place,catheter (1102) is withdrawn proximally as shown by FIG. 13.

After the prolapse has been corrected via the tightening and securing ofthe cord, the excess cord remaining in the heart must be cut and removedfrom the body. This may be accomplished in any number of ways. Forexample, a cutting catheter (1400) may be advanced distally throughtrans-septal sheath (204) as shown in. FIG. 14. As shown in that figure,cutting catheter (1400) has a cutting mechanism (1402) at its distalend. The cutting mechanism may be any suitable mechanism, and in thevariation shown in FIG. 14, it is a cutting wire having a loop. In thisvariation, the looped cutting wire is slid over the cord (400) andadvanced immediately proximal to the fastener (1104). The looped cuttingwire may be made of any suitable biocompatible cutting material, e.g.,stainless steel and the like. FIGS. 16A-16C illustrate a cutting wirecutting a cord. The excess cord is cut off, and both the excess cord(400) and the cutting catheter (1400) are removed proximally as shown byFIG. 15. The cord may also be cut at the same time that the fastener issecured and/or released. For example, the same device that deploys thefastener may also cut the cord. In some variations, the cord is cut atthe same time that the fastener is secured and/or released.

It should be noted that while the descriptions of the methods hereinhave focused on repair of mitral valve prolapse, the methods need not beso limited in application. For example, the methods may be used tocorrect tricuspid valve prolapse, or to provide a tensioned cord betweenany two areas of tissue requiring such. In addition, while the methodsdescribed here focused on a percutaneous trans-septal access, any methodof accessing the prolapsed valve is suitable, as noted above.

Kits

Kits for treating a mitral valve prolapse are also provided. In general,the kits comprise a flexible cord, having a proximal end and a distalend, a first anchor attached to the cord at its distal end andconfigured to secure the cord to cardiac tissue located below theprolapsed mitral valve leaflet, a second anchor for slidabe attachmentto the cord, wherein the second anchor is configured to secure into athe prolapsed mitral valve leaflet, and at least one catheter fordelivery of the flexible cord to the proximity of the prolapsed mitralvalve leaflet. Additional catheters may be included in the kits as well.

Any number of appropriate catheters may be used with devices and methodsdescribed herein, and may be included as part of a kit. For example,individual catheters may be used to deliver and/or implant the firstanchor and cord, to delivery and/or implant the second anchor, toreposition the valve leaflet, or to deliver and/or secure a fastener forthe cord. Additional catheters may also be included. In some variations,catheters may be combined. For example, a single catheter may be used todeliver and/or implant the second anchor and to reposition the leaflet.Thus, any of the catheters may be combined.

In addition, as evidenced by the description of the methods above, itmay be advantageous to provide a kit with additional tools useful incarrying out the described methods. For example, the kits may furthercomprise a cutting wire for cutting the cord, and/or a fastener. The kitmay also include instructions on how to use the contents of the kit.Instructions may include reference materials (including indications foruse, etc.) and be in any appropriate format, including written,pictographic, visual, electronic, etc., and be in any language, ormultiple languages.

As with the devices described above, at least one of the first or secondanchors may be made from a shape memory material, such as a nickeltitanium alloy. The first anchor may have a tissue piercing tip, whichmay further comprise two legs that may or may not be configured toexpand into cardiac tissue. Similarly, the cord may be made from amaterial selected from the group consisting of non-polymeric fabrics,polymers, and mixtures thereof. In some variations, the cord is madefrom a non-polymeric fabric and polymer mixture, such as a PTFE fabric.

Although specific embodiments of the present invention have beenillustrated in the accompanying drawings and described in the foregoingdetailed description, it will be understood that the invention is notlimited to the particular embodiments described herein, but is capableof numerous rearrangements, modifications, and substitutions withoutdeparting from the scope of the invention.

1. A device for treating a prolapsed mitral valve leaflet comprising: aflexible cord, having a proximal end and a distal end; a first anchorattached to the cord at its distal end and configured to secure the cordto cardiac tissue located below the prolapsed mitral valve leaflet; anda second anchor slidably attached to the cord and configured to secureinto the prolapsed mitral valve leaflet.
 2. The device of claim 1wherein the second anchor comprises two legs that are configured topierce mitral valve leaflet tissue.
 3. The device of claim 2 wherein thesecond anchor further comprises an eyelet.
 4. The device of claim 1further comprising a fastener.
 5. The device of claim 1 wherein at leastone of the first and second anchors is made from a shape memorymaterial.
 6. The device of claim 5 wherein the shape memory material isa nickel titanium alloy.
 7. The device of claim 1 wherein the cord ismade from a material selected from the group consisting of non-polymericfabrics, polymers, and mixtures thereof.
 8. The device of claim 7wherein the cord is made from a non-polymeric fabric and polymermixture.
 9. The device of claim 1 wherein the first anchor has a tissuepiercing tip.
 10. The device of claim 9 wherein the tip comprises twolegs.
 11. The device of claim 10 wherein the legs are configured toexpand after they are secured into cardiac tissue.
 12. The device ofclaim 1 wherein the cardiac tissue is selected from the group consistingof a papillary muscle and a ventricular wall.
 13. A method for treatinga prolapsed mitral valve leaflet comprising: advancing a flexible cord,having a first anchor attached at its distal end to the proximity of theprolapsed mitral valve leaflet; securing the first anchor to cardiactissue located below the prolapsed mitral valve leaflet; securing asecond anchor slidably attached to the cord into the prolapsed mitralvalve leaflet; and tensioning the cord after the second anchor has beensecured into the prolapsed mitral valve leaflet.
 14. The method of claim13 further comprising fixing the cord in its tensioned position.
 15. Themethod of claim 14 wherein fixing the cord further comprises applying afastener to the cord.
 16. The method of claim 15 further comprisingcutting the cord.
 17. The method of claim 16 wherein cutting the cordcomprises advancing a looped cutting wire over the cord; positioning thelooped cutting wire proximal of the second anchor; and pulling on thecutting wire to cut the cord.
 18. The method of claim 13 wherein thecardiac tissue is selected from the group consisting of a papillarymuscle and a ventricular wall.
 19. A method for treating a prolapsedvalve leaflet comprising: securing a first anchor to cardiac tissuelocated below the prolapsed valve leaflet; wherein the first anchor isattached to a flexible cord; securing a second anchor into the prolapsedvalve leaflet, wherein the second anchor is attached to the flexiblecord; and tensioning the cord after both anchors have been secured. 20.The method of claim 19, further comprising correcting the prolapsedvalve leaflet while tensioning the cord.
 21. The method of claim 19,further comprising fixing the cord in its tensioned position.
 22. Themethod of claim 19, wherein the valve leaflet is selected from the groupconsisting of a mitral valve leaflets and a tricuspid valve leaflets.23. The method of claim 19, wherein the second anchor is slideablyattached to the flexible cord.
 24. The method of claim 19, furthercomprising the step of advancing the flexible cord, wherein the flexiblecord is attached to the second anchor at the distal end of the flexiblecord.
 25. The method of claim 24, wherein the first anchor is slideablyattached to the flexible cord.
 26. The method of claim 19, whereinfixing the cord further comprises applying a fastener to the cord. 27.The method of claim 19 further comprising cutting the cord.
 28. A kitfor treating a prolapsed mitral valve leaflet comprising: a flexiblecord, having a proximal end and a distal end; a first anchor attached tothe cord at its distal end and configured to secure the cord to cardiactissue located below the prolapsed mitral valve leaflet; a second anchorfor slidabe attachment to the cord, wherein the second anchor isconfigured to secure into a the prolapsed mitral valve leaflet; and atleast one catheter for delivery of the flexible cord to the proximity ofthe prolapsed mitral valve leaflet.
 29. The kit of claim 28 furthercomprising at least one additional catheter.
 30. The kit of claim 28further comprising a cutting wire for cutting the cord.
 31. The kit ofclaim 28 further comprising a fastener.
 32. The kit of claim 28 whereinat least one of the first or second anchors is made from a shape memorymaterial.
 33. The kit of claim 32 wherein the shape memory material is anickel titanium alloy.
 34. The kit of claim 28 wherein the cord is madefrom a material selected from the group consisting of non-polymericfabrics, polymers, and mixtures thereof.
 35. The kit of claim 34 whereinthe cord is made from a non-polymeric fabric and polymer mixture. 36.The kit of claim 28 wherein the first anchor has a tissue piercing tip.37. The kit of claim 36 wherein the tip comprises two legs.
 38. The kitof claim 37 wherein the legs are configured to expand after they aresecured into cardiac tissue.
 39. The kit of claim 28 further comprisinginstructions on how to use the contents of the kit.